Actively Recruiting
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
Led by Estrella Biopharma, Inc. · Updated on 2025-08-07
21
Participants Needed
2
Research Sites
186 weeks
Total Duration
On this page
Sponsors
E
Estrella Biopharma, Inc.
Lead Sponsor
E
Eureka Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.
CONDITIONS
Official Title
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically confirmed relapsed or refractory B-cell non-Hodgkin's lymphoma
- Adequate organ function
- Relapsed or refractory disease after at least 2 lines of systemic therapy, or after 1 line for Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma
- Disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation (HSCT)
- For transplant-ineligible subjects: progressive disease after 4 or more cycles of first-line therapy and stable disease after 2 or more cycles of second-line therapy; must have received an anti-CD20 monoclonal antibody and an anthracycline as part of treatment
- Must have received chemoimmunotherapy including an anti-CD20 monoclonal antibody and an anthracycline-containing chemotherapy
- Positron emission tomography (PET)-positive disease according to Cheson 2014 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Toxicities from prior therapies must be stable and recovered to Grade 1 or less
You will not qualify if you...
- Prior CD19-targeted cellular therapy
- History of Richter's transformation of chronic lymphocytic leukemia (CLL)
- History of another primary malignancy not in remission for at least 2 years
- History or presence of clinically relevant central nervous system (CNS) pathology
- CNS disease progressing on most recent therapy or with a symptomatic parenchymal mass
- Active cardiac lymphoma not responding to treatment
- Recent significant cardiac events or diseases within 6 months before informed consent
- Active, uncontrolled systemic bacterial, fungal, or viral infections
- Autoimmune disease causing end organ injury or requiring systemic immunosuppression within the last 2 years
- Severe immediate hypersensitivity to agents used in this study
- Venous thrombosis or embolism not stabilized on anticoagulation
- Autologous HSCT within 3 months before informed consent
- Ongoing graft-versus-host disease treatment within 12 weeks for those with prior allogeneic transplant
- Live vaccine within 3 months before starting conditioning regimen
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Baylor Scott & White Research Institute, Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
T
Teresa Klask, MBA
CONTACT
P
Pei Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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